Nasopharyngeal Cancinoma (NPC)Phase 2/3NCT06854510
Sodium Bicarbonate for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
A Phase 2/3 study testing Gargle with 2.5% sodium bicarbonate solution during radiotherapy and Gargle with 0.9% sodium chloride solution during radiotherapy in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate whether the use of 2.5% sodium bicarbonate mouthwash throughout the entire course of radiotherapy for nasopharyngeal carcinoma reduces the severity of radiation-induced oral mucositis and improves patient adherence to treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Gargle with 2.5% sodium bicarbonate solution during radiotherapy and Gargle with 0.9% sodium chloride solution during radiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2025to Feb 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed nasopharyngeal carcinoma.
- No evidence of distant metastasis (M0).
- Scheduled to receive radical radiotherapy.
- Karnofsky scale (KPS) > 70.
- Age 18-70 years.
- Capacity for independent oral rinse administration without dysphagia.
Who cannot join
- Patients receiving non-platinum-based concurrent chemotherapy regimens.
- Radiation fields encompassing level Ib lymph nodes.
- History of pre-existing oral mucosal disorders or recurrent oral ulceration.
- Prior radiotherapy history.
- Severe coexisting illness.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-Center, Randomized Controlled Study on Sodium Bicarbonate Mouthwash for the Prevention and Treatment of Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
To evaluate whether the use of 2.5% sodium bicarbonate mouthwash throughout the entire course of radiotherapy for nasopharyngeal carcinoma reduces the severity of radiation-induced oral mucositis and improves patient adherence to treatment.
Read the detailed description
With the improvement in the prognosis of locally advanced nasopharyngeal carcinoma (LA-NPC) patients, an increasing number of studys have turned their attention to the treatment-related toxicities in NPC patients. Common toxic reactions during the treatment of NPC patients include radiation-induced oral mucositis, radiation-induced skin injury, dysphagia, xerostomia, and hearing loss, etc. Among them, radiation - induced oral mucositis is one of the most common and severe complications during radiotherapy for NPC patients. More than half of LA-NPC will experience grade 3 - 4 radiation-induced oral mucositis.
Current international guidelines, including those from NCCN, ESMO, and the Multinational Association of Supportive Care in Cancer (MASCC), provisionally endorse sodium bicarbonate mouthwash as an adjunctive measure for RIOM management. The proposed mechanisms involve pH modulation of the oral cavity, microbial load reduction, and anti-inflammatory effects. Specifically: 1) NCCN guidelines incorporate sodium bicarbonate into multi-agent regimens with analgesics/anesthetics; 2) ESMO emphasizes its prophylactic potential in targeted therapy-associated mucositis; 3) MASCC consensus acknowledges its role in maintaining oral hygiene. However, these recommendations carry low evidence grades, with all guidelines explicitly highlighting the paucity of robust clinical data to substantiate efficacy claims.
To address this critical evidence gap, our research team proposes a randomized controlled trial to evaluate the efficacy of sodium bicarbonate mouthwash in mitigating RIOM severity throughout radiotherapy for LA-NPC. Given the current lack of high - level research evidence, the results of future research are expected to further confirm the effectiveness of sodium bicarbonate mouthwash in relieving radiation-induced oral mucositis during radiotherapy for NPC patients, improve the quality of life of NPC patients.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Gargle with 2.5% sodium bicarbonate solution during radiotherapy, Gargle with 0.9% sodium chloride solution during radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gargle with 2.5% sodium bicarbonate solution during radiotherapyDrug
In addition to routine oral care, patients received sodium bicarbonate solution gargle therapy from the initiation of radiotherapy until its completion. The treatment protocol is as follows:
For patients with oral mucositis of grade 0 - 1, gargle with a 2.5% sodium bicarbonate solution (for 1 - 2 minutes each time) three times a day and spit out the liquid after each gargle. For patients with oral mucositis of grade ≥ 2, gargle with a 2.5% sodium bicarbonate solution (for 1 - 2 minutes each time) four to five times a day and spit out the liquid after each gargle.
Gargle with 0.9% sodium chloride solution during radiotherapyDrug
In addition to routine oral care, patients received 0.9% sodium chloride solution gargle therapy from the initiation of radiotherapy until its completion. The treatment protocol is as follows: For patients with oral mucositis of grade 0 - 1, gargle with a 0.9% sodium chloride solution (for 1 - 2 minutes each time) three times a day and spit out the liquid after each gargle. For patients with oral mucositis of grade ≥ 2, gargle with a 0.9% sodium chloride solution (for 1 - 2 minutes each time) four to five times a day and spit out the liquid after each gargle.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Bicarbonate Solution Gargle Group | Experimental | Oral rinses using 2.5% sodium bicarbonate solution were administered daily throughout the radiotherapy course Receives: Drug: Gargle with 2.5% sodium bicarbonate solution during radiotherapy |
| Sodium Chloride Solution Gargle Group | Placebo comparator | Oral rinses using 0.9% sodium chloride solution were administered daily throughout the radiotherapy course Receives: Drug: Gargle with 0.9% sodium chloride solution during radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade ≥2 oral mucositis
Oral mucositis grade was evaluated using RTOG (Radiation Therapy Oncology Group) criteria, with intergroup differences analyzed by Chi-square test.
Measured: from radiotherapy commencement until 14 days post-radiotherapy
Secondary outcomes (4)
The incidence of grade ≥3 oral mucositis
Oral mucositis grade was evaluated using RTOG (Radiation Therapy Oncology Group) criteria, with intergroup differences analyzed by Chi-square test.
Measured: from radiotherapy commencement until 14 days post-radiotherapy
The incidence of grade ≥1 oral mucositis
Oral mucositis grade was evaluated using RTOG (Radiation Therapy Oncology Group) criteria, with intergroup differences analyzed by Chi-square test.
Measured: from radiotherapy commencement until 14 days post-radiotherapy
Oral fungal detection rate
Fungal culture testing via oral swab should be performed when oral mucositis of grade ≥2 severity occurs.
Measured: from radiotherapy commencement until 14 days post-radiotherapy
Rate of oral pH decline
Weekly electronic pH meter measurements were obtained pre-radiotherapy and during radiotherapy, with comparison of the decline rate from baseline to pH nadir.
Measured: from radiotherapy commencement until 14 days post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start21 Feb 2025
- Primary completion15 Feb 2026
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Long Tang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854510
- Sponsor's protocol ID
- B2025-016-01
- Status last verified
- Jul 2026
- First submitted
- 20 Feb 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Randomized Controlled Study on Sodium Bicarbonate Mouthwash for the Prevention and Treatment of Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
- ClinicalTrials.gov ID
- NCT06854510
- Acronym / sponsor ID
- B2025-016-01
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- Feb 2030 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether the use of 2.5% sodium bicarbonate mouthwash throughout the entire course of radiotherapy for nasopharyngeal carcinoma reduces the severity of radiation-induced oral mucositis and improves patient adherence to treatment.
Detailed description
With the improvement in the prognosis of locally advanced nasopharyngeal carcinoma (LA-NPC) patients, an increasing number of studys have turned their attention to the treatment-related toxicities in NPC patients. Common toxic reactions during the treatment of NPC patients include radiation-induced oral mucositis, radiation-induced skin injury, dysphagia, xerostomia, and hearing loss, etc. Among them, radiation - induced oral mucositis is one of the most common and severe complications during radiotherapy for NPC patients. More than half of LA-NPC will experience grade 3 - 4 radiation-induced oral mucositis.
Current international guidelines, including those from NCCN, ESMO, and the Multinational Association of Supportive Care in Cancer (MASCC), provisionally endorse sodium bicarbonate mouthwash as an adjunctive measure for RIOM management. The proposed mechanisms involve pH modulation of the oral cavity, microbial load reduction, and anti-inflammatory effects. Specifically: 1) NCCN guidelines incorporate sodium bicarbonate into multi-agent regimens with analgesics/anesthetics; 2) ESMO emphasizes its prophylactic potential in targeted therapy-associated mucositis; 3) MASCC consensus acknowledges its role in maintaining oral hygiene. However, these recommendations carry low evidence grades, with all guidelines explicitly highlighting the paucity of robust clinical data to substantiate efficacy claims.
To address this critical evidence gap, our research team proposes a randomized controlled trial to evaluate the efficacy of sodium bicarbonate mouthwash in mitigating RIOM severity throughout radiotherapy for LA-NPC. Given the current lack of high - level research evidence, the results of future research are expected to further confirm the effectiveness of sodium bicarbonate mouthwash in relieving radiation-induced oral mucositis during radiotherapy for NPC patients, improve the quality of life of NPC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate Solution Gargle Group | Experimental | Drug: Gargle with 2.5% sodium bicarbonate solution during radiotherapyOral rinses using 2.5% sodium bicarbonate solution were administered daily throughout the radiotherapy course |
| Sodium Chloride Solution Gargle Group | Placebo comparator | Drug: Gargle with 0.9% sodium chloride solution during radiotherapyOral rinses using 0.9% sodium chloride solution were administered daily throughout the radiotherapy course |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed nasopharyngeal carcinoma.
- No evidence of distant metastasis (M0).
- Scheduled to receive radical radiotherapy.
- Karnofsky scale (KPS) > 70.
- Age 18-70 years.
Key exclusion criteria (6 listed)
- Patients receiving non-platinum-based concurrent chemotherapy regimens.
- Radiation fields encompassing level Ib lymph nodes.
- History of pre-existing oral mucosal disorders or recurrent oral ulceration.
- Prior radiotherapy history.
- Severe coexisting illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gargle with 2.5% sodium bicarbonate solution during radiotherapyIn addition to routine oral care, patients received sodium bicarbonate solution gargle therapy from the initiation of radiotherapy until its completion. The treatment protocol is as follows: For patients with oral mucositis of grade 0 - 1, gargle with a 2.5% sodium bicarbonate solution (for 1 - 2 minutes each time) three times a day and spit out the liquid after each gargle. For patients with oral mucositis of grade ≥ 2, gargle with a 2.5% sodium bicarbonate solution (for 1 - 2 minutes each time) four to five times a day and spit out the liquid after each gargle. | Drug | Sodium Bicarbonate Solution Gargle Group |
| Gargle with 0.9% sodium chloride solution during radiotherapyIn addition to routine oral care, patients received 0.9% sodium chloride solution gargle therapy from the initiation of radiotherapy until its completion. The treatment protocol is as follows: For patients with oral mucositis of grade 0 - 1, gargle with a 0.9% sodium chloride solution (for 1 - 2 minutes each time) three times a day and spit out the liquid after each gargle. For patients with oral mucositis of grade ≥ 2, gargle with a 0.9% sodium chloride solution (for 1 - 2 minutes each time) four to five times a day and spit out the liquid after each gargle. | Drug | Sodium Chloride Solution Gargle Group |
Primary outcome
The incidence of grade ≥2 oral mucositis
Time frame: from radiotherapy commencement until 14 days post-radiotherapy
Oral mucositis grade was evaluated using RTOG (Radiation Therapy Oncology Group) criteria, with intergroup differences analyzed by Chi-square test.
4 secondary outcomes
The incidence of grade ≥3 oral mucositis
Time frame: from radiotherapy commencement until 14 days post-radiotherapy
The incidence of grade ≥1 oral mucositis
Time frame: from radiotherapy commencement until 14 days post-radiotherapy
Oral fungal detection rate
Time frame: from radiotherapy commencement until 14 days post-radiotherapy
Rate of oral pH decline
Time frame: from radiotherapy commencement until 14 days post-radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gargle with 2.5% sodium bicarbonate solution during radiotherapy and Gargle with 0.9% sodium chloride solution during radiotherapy in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade ≥2 oral mucositis (time frame: from radiotherapy commencement until 14 days post-radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.